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Review
. 2014 Dec;48(3):392-401.
doi: 10.1007/s12160-014-9618-7.

Approaches for informing optimal dose of behavioral interventions

Corrine I Voils  1 , Heather A King, Matthew L Maciejewski, Kelli D Allen, William S Yancy Jr, Jonathan A Shaffer
Affiliations
Review

Approaches for informing optimal dose of behavioral interventions

Corrine I Voils et al. Ann Behav Med. 2014 Dec.

Abstract

Background: There is little guidance about to how select dose parameter values when designing behavioral interventions.

Purpose: The purpose of this study is to present approaches to inform intervention duration, frequency, and amount when (1) the investigator has no a priori expectation and is seeking a descriptive approach for identifying and narrowing the universe of dose values or (2) the investigator has an a priori expectation and is seeking validation of this expectation using an inferential approach.

Methods: Strengths and weaknesses of various approaches are described and illustrated with examples.

Results: Descriptive approaches include retrospective analysis of data from randomized trials, assessment of perceived optimal dose via prospective surveys or interviews of key stakeholders, and assessment of target patient behavior via prospective, longitudinal, observational studies. Inferential approaches include nonrandomized, early-phase trials and randomized designs.

Conclusions: By utilizing these approaches, researchers may more efficiently apply resources to identify the optimal values of dose parameters for behavioral interventions.

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Conflict of interest statement

Authors’ Statement of Conflict of Interest and Adherence to Ethical Standards Authors Voils, King, Allen, Yancy, and Shaffer declare that they have no conflict of interest. Dr. Maciejewski has received consultation funds from Daichi Sankyo and ResDAC at the University of Minnesota, and owns stock in Amgen due to his spouse’s employment. All procedures, including the informed consent process, were conducted in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000.

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